Legislation/Regulation > Government Resource

Federal Register. Washington, DC: Office of the National Coordinator for Health Information Technology, Department of Health and Human Services. 2016;81:72404-72471.

Requirements are needed to manage risks associated with health information technology systems. This final rule provides a framework for government review of technologies certified by the ONC Health IT Certification Program. The rule also covers certification guidance for testing laboratories. The regulations go into effect December 19, 2016.

This proposed rule suggests updates to the government requirements hospitals must comply with to participate in Medicare and Medicaid. Changes include emphasis on the role of leadership engagement and safety culture as ways to generate improvements in areas such as reducing hospital-acquired infections and readmissions. Comments on the proposed rule are due August 15, 2016.

Legislation/Regulation > Government Resource

Agency for Healthcare Research and Quality. Fed Regist. 2016;81;32655-32660.

Patient Safety Organizations (PSOs) were formed with provisions to protect voluntarily submitted incident data to enhance transparency and learning from medical error. Despite those expectations, PSOs still have obligations to report certain situations to external organizations. This guidance aims to clarify what and when external reporting should take place for PSOs to remain in compliance with federal requirements while appropriately protecting incident data.

Poor safety culture and lack of available resources to provide high-quality care can hinder safety in long-term care facilities. This set of regulations will revise requirements for long-term care facilities in areas such as clinical practice standards, service delivery, patient-centeredness, and infection control. The deadline for officially submitting comments on the proposed rule was September 14, 2015.

Heparin is a high-alert anticoagulant that has been associated with patient harm due to issues with administration and contamination. This draft guidance seeks to engage insights from the field to help improve labeling practices. The deadline for officially submitting comments was October 7, 2015.

Legislation/Regulation > Government Resource

US Department of Health and Human Services; Agency for Healthcare Research and Quality; Federal Register. November 21, 2008;73:70731-70814.

This final rule outlines how to become a Patient Safety Organization (PSO), and supports AHRQ action to receive applications from qualified entities that wish to become PSOs. The interim guidance will remain in effect until January 19, 2009, the official activation date for the final rule.

Legislation/Regulation

The U.S. Food and Drug Administration (FDA) is proposing to amend good manufacturing practice to include several strategies for minimizing medical gas-related patient safety incidents. The proposal is open for public comment through July 10, 2006.

Legislation/Regulation > Government Resource

US Food and Drug Administration, HHS. Final rule. Fed Regist. February 26, 2004;69(38):9119-9171.

The US Food and Drug Administration (FDA) requires certain human drug and biological product labels to contain bar codes. The rule aims to reduce the number of medication errors by allowing health care professionals to use bar code scanning equipment for necessary verification. This protects against an incorrect drug administration. Effective date: April 26, 2004.